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Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv10 Show 6 more changesShow less
    • Enrollment target: 110 to 99
    • Primary completion date: Sep 30, 2027 to Nov 30, 2026
    • Study completion date: Dec 30, 2027 to Jun 30, 2027
    • Secondary endpoints: details revised at 9 of 9 entries
    • Site details revised at 13 of 13 sites
    • Study description expanded, about 1 word
  2. Site contacts updated at 1 of 13 sitesv9
  3. Primary completion date: Mar 30, 2025 to Sep 30, 2027
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 9 to 13
    • Study completion date: Dec 30, 2025 to Dec 30, 2027
    v8
  4. Study sites: 7 to 9v7
  5. Study sites: 3 to 7v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date changed from estimate of Jan 30, 2023 to Feb 1, 2023v5
  2. Start date: Sep 15, 2022 to Jan 30, 2023
    • Eligibility criteria expanded, about 2 words
    v4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date: Jun 18, 2022 to Sep 15, 2022
    • Study sites: 2 to 3
    • Secondary endpoints: details revised at 1 of 9 entries
    v3
  4. Study sites: 1 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (up to 24-months) of study participants.
Trial Details
NCT Number NCT05362370
Lead Sponsor Stryker Craniomaxillofacial
Collaborators: Qmed Consulting A/S
Conditions
(from sponsor)		 Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
Related terms Craniofacial Abnormalities
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov